Panels › General Hospital › Product code FRN · Class 2
Pump, Infusion
Regulation 880.5725
2510(k)s in 12 months (849 all time)
24recalls in 12 months (724 all time)
672recalls that name a 510(k)
Top companies in FRN
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 51 | 128 |
| Hospira, Inc. | 12 | 129 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 78 |
| Abbott Laboratories | 67 | 4 |
| Carefusion 303, Inc. | 4 | 61 |
| Icu Medical, Inc. | 4 | 43 |
| Smiths Medical Asd, Inc. | 1 | 42 |
| B.Braun Medical, Inc. | 11 | 22 |
| Y | 26 | 0 |
| Zevex International, Inc. | 0 | 25 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 9, 1981 | K803183 | OFFENBACK REVERSIBLE BARIUM PUMP The Offenback Co. | FRN |
| Jun 2, 1981 | K811238 | MODEL 560 SERIES VOLUMETRIC INFUSION Y | FRN |
| Mar 20, 1981 | K810295 | COMPUTER INTERFACE MODULE Y | FRN |
| Mar 17, 1981 | K810252 | STUMARK INFUSOR Stumark Corp. | FRN |
| Jan 28, 1981 | K803078 | SIMPLICITY INFUSION PUMP MODEL 2100A Critikon Company, LLC | FRN |
| Jan 9, 1981 | K803190 | ETHOX/BARRON #2000 FOOD PUMP-ENTERAL FED Ethox Corp. | FRN |
| Dec 17, 1980 | K802901 | TRAVENOL INFUSION PUMP-2M8016 Travenol Laboratories, S.A. | FRN |
| Dec 16, 1980 | K802400 | MS 16 SYRINGE DRIVER Princeton Medical Instruments, Inc. | FRN |
| Dec 10, 1980 | K802820 | TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP) Travenol Laboratories, S.A. | FRN |
| Oct 23, 1980 | K802301 | CORDIS DOW INFUSION PUMP Cordis Corp. | FRN |
| Aug 27, 1980 | K801904 | SYRINGE INFUSION PUMP #2716 Harvard Apparatus, Inc. | FRN |
| Aug 27, 1980 | K801546 | THE SIMPLICITY PUMP #2100 INFUSION PUMP Critikon Company, LLC | FRN |
| Aug 13, 1980 | K801725 | KANGAROO ENTERAL FEEDING PUMP Chesebrough-Pond'S U.S.A. Co. | FRN |
| Aug 13, 1980 | K801704 | OPEN-LOOP INSULIN DELIVERY SYSTEM Delta Medical Industries | FRN |
| Aug 12, 1980 | K801441 | ABBOTT/SHAW LIFE CARE PUMP MODEL 3 Abbott Laboratories | FRN |
| Jul 14, 1980 | K800627 | AMBULATORY INFUSION PUMP, CODE 2M9807 Travenol Laboratories, S.A. | FRN |
| May 14, 1980 | K800629 | INTRAVENOUS INFUSION PUMP, CODE 2M8015 Travenol Laboratories, S.A. | FRN |
| Apr 16, 1980 | K800570 | HEPARIN PUMP #7420 Bd Becton Dickinson Vacutainer Systems Preanalytic | FRN |
| Apr 8, 1980 | K800569 | SYRINGE INFUSION PUMP #2720 Harvard Apparatus, Inc. | FRN |
| Mar 10, 1980 | K792050 | 3M SMALL VOLUME INFUSTION (SVI) SYSTEM 3M Company | FRN |
| Nov 29, 1979 | K792142 | MODEL IV 6500 FORMULATOR Valleylab, Inc. | FRN |
| Nov 13, 1979 | K791293 | BATTERY POWERED SYRINGE INFUSION PUMP Harvard Apparatus, Inc. | FRN |
| Nov 5, 1979 | K791720 | AR/MDE INFUSOR MODEL 60/2 INFUSION PUMP Alza Corp. | FRN |
| Oct 1, 1979 | K791729 | SYRINGE INFUSION PUMP Princeton Medical Instruments, Inc. | FRN |
| Sep 12, 1979 | K791528 | FLEXIFO ENTERAL NUTRITION PUMP Abbott Laboratories | FRN |
| Jun 27, 1979 | K790814 | DELTA PUMP Spiess Design, Inc. | FRN |
| Jun 1, 1979 | K790945 | MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU Vickers America Medical Corp. | FRN |
| Jun 1, 1979 | K790559 | ALARM Maddak, Inc. | FRN |
| May 15, 1979 | K790315 | BLOOD CELL SEPARATOR SYSTEM CS3000 Travenol Laboratories, S.A. | FRN |
| Apr 10, 1979 | K790373 | IVAC 630 VOLUMETRIC INFUSION PUMP Y | FRN |
| Apr 10, 1979 | K790332 | MODEL IV6000 INFUSION PUMP Valleylab, Inc. | FRN |
| Feb 27, 1979 | K782034 | INFUSION PUMP, MODEL AS*5 Baxter Healthcare Corp | FRN |
| Jan 17, 1979 | K782020 | INFUSION PUMP, MODEL 5000 Sigmamotor, Inc. | FRN |
| Jan 17, 1979 | K782019 | CUTTER 888-00 INFUSION PUMP Sigmamotor, Inc. | FRN |
| Aug 10, 1978 | K781171 | INFUSION PUMP, PEDIATRIC MODEL 301 Imed Corp. | FRN |
| May 19, 1978 | K780705 | INFUSION PUMP-MODEL 2616 Harvard Apparatus, Inc. | FRN |
| Apr 10, 1978 | K780503 | INFUSION PUMP Air-Shields, Inc. | FRN |
| Jan 30, 1978 | K780086 | INFUSION APPARATUS, POWERED Ohio Medical Products | FRN |
| Dec 8, 1977 | K772094 | LIFECARE I.V. PUMP - MODEL III Abbott Laboratories | FRN |
| Dec 8, 1977 | K771300 | INTRAVENOUS INFUSION PUMP Stewart-Naumann Laboratories | FRN |
| Sep 12, 1977 | K771664 | VOLUMETRIC INFUSION PUMP MODEL 960 Imed Corp. | FRN |
| Aug 22, 1977 | K771478 | INFUSION PUMP #6202 Roche Medical Electronics, Inc. | FRN |
| Jul 14, 1977 | K770849 | VOLUMET INFUSION PUMP, MODIFI. OF Sigmamotor, Inc. | FRN |
| Jul 11, 1977 | K770730 | PUMP, INFUSION, DYNATECH/HANDLEY Dynatech Medical Products | FRN |
| Feb 14, 1977 | K770087 | I.V. PUMP, ABBOTT/SHAW LIFECARE Abbott Laboratories | FRN |
| Jan 6, 1977 | K761307 | AUTO SYRINGE MODEL AS-3A Baxter Healthcare Corp | FRN |
| Dec 9, 1976 | K761151 | INFUSION PUMP Travenol Laboratories, S.A. | FRN |
| Oct 14, 1976 | K760718 | PERISTALTIC INFUSION PUMP (2100,2101) Extracorporeal Medical Specialities, Inc. | FRN |
| Aug 23, 1976 | K760370 | INFUSION EQUIPMENT, INTRAVENOUS Valleylab, Inc. | FRN |
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